United States Pivotal Trial Begins for Essential Medical's Manta Vascular Closure Device

December 12, 2016–Essential Medical, Inc. announced the start of the MANTA United States pivotal trial for the company's Manta vascular closure device.

According to the company, the Manta device is designed to close punctures ranging from 10 to 24 F at femoral arterial access sites after cardiac catheterization procedures, such as transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR) treatment of abdominal aortic aneurysms, ventricular assist, and balloon aortic valvuloplasty.

Itsik Ben-Dor, MD, performed the first United States case on November 28 at the Washington Hospital Center in Washington, DC. After successfully implanting a 34-mm CoreValve Evolut R TAVR device (Medtronic), the 21-F arteriotomy was closed with the 18-F Manta device, which provided immediate hemostasis and a clear patent vessel.

David Wood, MD, coprincipal investigator of the trial, was onsite for the case. In the company's press release, Dr. Wood commented, "The team in Washington did a great job implanting the first 18 F Manta closure device in North America. The result was excellent and we are keen to start enrolling patients in the trial. This technology has the potential to be a real game changer for transfemoral TAVR." Dr. Wood is a founding member of the Center for Heart Valve Innovation in Vancouver, British Columbia.

The second TAVR patient in the trial was enrolled by Zvonimir Krajcer, MD, at Texas Heart in Houston, Texas. Dr. Krajcer is coprincipal investigator of the MANTA trial and codirector of the Peripheral Vascular Disease Service at Texas Heart. He successfully closed a 23-F arteriotomy with the 18-F Manta device and achieved immediate hemostasis, reported the company.

After the first two TAVR implantations in North America, Dr. Krajcer led efforts in the first MANTA trial closure after an EVAR procedure. The successful EVAR was performed using an Ovation iX stent graft (Endologix, Inc.), creating a 14-F arteriotomy closed with the 14-F Manta device. Hemostasis was achieved in under 30 seconds, reported Essential Medical.